NCT05066412Recruiting
Prophylactic CD45RA-depleted DLI After Haploidentical Transplantation/RIC
Summary
To assess safety of prophylactic escaladed dose of T naïve depleted (CD45RA depleted donor lymphocyte infusion, in patients with malignant hemopathie who received an allogeneic stem cell transplant from an haplo-identical donor, after a reduced intensity conditionning regiment.
Inclusion criteria
• Patients who received a stem cell graft from a haploidentical donor after RIC for hematologic malignancies • Written informed consent of patient and donor obtained
Exclusion criteria
• Participant taking Prednisone (or equivalent steroid) • Participant taking Prednisone (or equivalent steroid) • Participant taking Mycophenolate Mofetil • Participant taking Cyclosporine/tacrolimus at therapeutic blood levels • Progressive hematologic malignancy before transplant • Second allogeneic transplant • Acute GvHD ≥ grade 2 • Chronic moderate or severe GvHD (NIH consensus criteria) • Hematologic or molecular relapse of the primary malignancy requiring chemotherapy or unmanipulated DLI (receiving prophylactic antileukemic agent, eg TKI, is not an exclusion criteria) • Donor aberrant CD45RA expression due to a polymorphism in CD45 gene • Participation in another interventional clinical trial within 30 days prior to inclusion • Pregnant or nursing women. Sexually active women with childbearing potential as well as sexually active male patients who are unwilling to use an effective method of contraception during participation in the study from time of inclusion until 2 months after last dose of CD45RAneg DLI infusion • Inability to follow the procedures of the study, including, but not limited to, language problems, psychological disorders, dementia
Contacts
The trial team's contact details are shown on request.
See the official trial record- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Countries
- Switzerland
- Sponsor
- University Hospital, Geneva(Other)
- Protocol no.
- Cd45RA depleted DLI
- Conditions
- Hematologic Malignancy, Haplo-identical Stem Cell Transplantation
- Interventions
- Other
Treatments studied
- CD45RAneg cells, prepared from mononuclear cell leukapheresis by CliniMACS® technology
Locations · 1
- Geneva, SwitzerlandHUGRecruiting at this site
In total, worldwide, the only site listed in the registry is recruiting.
Site status per the ClinicalTrials.gov registry (last update posted: February 13, 2025).
This status may have changed and says nothing about your eligibility: before taking any step, check with your oncologist or the site.
See also
Other versions
These results are indicative and do not replace medical advice — discuss them with your doctor.